MAUDE Adverse Event Report: ALCON CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE

Lot Number 268627F

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Burning Sensation (2146)

Event Date 04/07/2017

Event Type  Injury  

Event Description

Other serious/important medical incident: severe eye irritation.I soaked my contact lenses in a new bottle of clear care solution with a new clear care case.My lenses soaked for over 12 hours.When i inserted the right contact in my eye severe burning occurred.I have used this product for years without incident but this occurred with the first use of this new box (bottle and associated case).Is the product over-the-counter: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Do you still have the product in case we need to evaluate it: yes.Why was the person using the product: to clean contact lenses.

• Brand Name: CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE
• Type of Device: CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6480433
• MDR Text Key: 72560954
• Report Number: MW5069013
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Lot Number: 268627F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR